The present invention relates generally to improved drug delivery devices, preferably for use by children and infants, and to methods of delivering drugs using same. More particularly, the present invention provides an incentive inhaler device comprising (i) an inhalation device comprising a mask or mouthpiece and a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas; and (ii) one or more external visible and/or audible inhalation/exhalation-driven incentive toys, wherein each of said toys is separated from one or more components of said inhalation device (i) by one or more valves, filters or baffles to ensure directional flow of inhaled/exhaled air which drives said toys. Preferably, said valves that ensure directional air flow air are positioned within a conduit that provides for the attachment of said inhalation/exhalation-driven incentive toy(s) Replaceable filters or baffles between the mask and the toy assembly and/or between the mask and the connector or spacer may additionally provide filtration of particles or moisture in exhaled air which might otherwise contaminate the toys or the connector or spacer. Preferably, said conduit is positioned between said inhalation/exhalation mask or mouthpiece and said connector for a drug delivery device or other device for the delivery of an aerosol, powder or gas. Preferably, the modular incentive inhaler device of the present invention further includes a spacer positioned between said inhalation/exhalation mask and said connector. More preferably, the modular incentive inhaler device of the present invention further includes a spacer positioned between said inhalation/exhalation mask or mouthpiece and said conduit, or alternatively, between said conduit and said connector.
Those skilled in the art will be aware that the invention described herein is subject to variations and modifications other than those specifically described. It is to be understood that the invention described herein includes all such variations and modifications. The invention also includes all such steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any two or more of said steps or features.
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A significant problem faced by the pharmaceutical industry is the need for effective means for the delivery of drugs to infants and children, in particular drugs in the form of aerosols, powders or gases which are administered by inhalation. A suitable means for the delivery of anaesthetics, and many medicaments for the treatment of respiratory ailments such as asthma, to a patient in need of treatment, is by inhalation of the drug into the airways. To achieve the delivery of gases, powders and aerosols to patients"" airways, a large number of different drug delivery means have been developed including, for example, gas-borne inhalers such as asthma pumps or Metered Dose Inhalers (MDI), dry powder inhalers, breath-activated inhalers and nebulisers.
However, therapeutic regimes for the administration of aerosols, powders or gases to infants and children are often sub-optimal, because of the difficulty which this group faces in using devices for their inhalation. The efficient delivery of air-borne drugs from standard inhalation devices requires the patient to time manual activation of a drug delivery device with inhalation of the drug released therefrom, generally by achieving a slow-flow deep inspiration and adequate breath-holding, which infants and small children often find difficult to achieve without considerable training. As a consequence, many drugs delivered from standard inhalation devices are not administered efficiently to infants and small children.
There is a clear need to foster correct breathing patterns in infants and small children who use conventional inhalation devices. The lack of guidance or an incentive or encouragement in the proper use of conventional inhalation devices, for example the incentive to breathe with a pattern of normal tidal breathing, rather than with shallow hyperventilation, is clearly a disadvantage associated with the present technology.
Moreover, small children and infants typically find standard inhalation devices frightening and, as a consequence, refuse to use them. Faced with strong resistance from children, many care-givers responsible for administering medication to children report a reluctance to offer air-borne drugs for use with standard inhalation devices on a regular basis. In addition, care-givers also report that even when attempted, the delivery of aerosol/gas medication to children is often sub-optimal because the child cries and/or forcibly removes the mask from their face before the medication is taken properly.
Inhalation devices have been described which employ some form of audio or visual warning or notification of the passage of inhaled air, to ensure that the pharmaceutical drug ejected from the drug delivery means actually reaches the patient. For example, U.S. Pat. No. 4,984,158; Australian Patent No. 620375; Australian Patent No. 618789; U.S. Pat. Nos. 5,042,467; 5,363,842; 5,431,154; 5,522,380; United Kingdom Patent Application No. 2 299 512A; U.S. Pat. No. 5,758,638; French Patent Application No. 2 763 507A, and International Patent Publication No. WO 94/44974 all describe such inhalation devices.
However, inhaler devices which merely provide for an audible or visual signal to monitor a correct breathing pattern or drug delivery do not generally utilise a signal that is both capable of simple interpretation by an infant or small child, without reference to medical personnel to determine whether or not the signal generated is appropriate, and further, comprise a signal that is sufficiently pleasant to provide an inducement for their correct use by infants and small children Accordingly, such devices do not address the significant problem of overcoming the fear which children and small infants have of medical devices or encourage this user group to use inhalation devices.
A further problem encountered with conventional signalling inhalation devices is that the device becomes contaminated through use, with residual medicament that is contained in exhaled air. Additionally, when inhalation devices are used interchangeably with different drug delivery sources or MDls to administer different chemical compounds, significant cross-contamination with the different chemical compounds may occur. Accordingly, a further object of the present invention is to provide an inhalation device that does not become easily contaminated with exhaled air/medicament mixtures and is kept cleaner than conventional signalling inhalation devices.
In work leading up to the present invention, the inventors sought to develop an inhalation device that would provide an incentive to a child or small infant user as well as overcome the drug contamination problems associated with conventional devices.
The inventors realised that the signal provided by such a device must be both pleasant and provide a positive feedback to the user, in order to provide the requisite inducement. In general, devices which provide a negative feedback rather than a positive feedback to a child user, such as those which provide a visual or audible signal only during incorrect use, will not provide the necessary inducement For example, U.S. Pat. No. 5,042,467 describes a medication inhaler that includes an internal air-operated auditory warning device that generates a pleasant musical tone to alert a user that he/she is inhaling too vigorously or rapidly.
In this regard, the present invention motivates a child to inhale willingly and effectively by the use of one or more breath-driven (i.e. inhalation/exhalation-driven) incentive toys attached to a conventional inhalation apparatus In use, the reward enjoyed by the infant or small child is directly proportional to the efficiency of inhalation and the amount of medication administered to the patient. The modular incentive inhaler device of the present invention also fosters a correct breathing technique in the child, because shallow breathing, such as hyperventilation, is insufficient to adequately activate the incentive toys. By these means, asthmatic, emphysemic and other sick children/infants are effectively treated, and encouraged to overcome their fear and mistrust of inhalers and gas/aerosol/powder delivery devices.
In work leading up to the present invention, the inventors also realised that the mere attachment of toys to a conventional inhaler device, whilst providing an incentive to the juvenile user, did not overcome the further problem of contamination with the medicament contained in inhaled or exhaled air The inventors overcame contamination of the incentive toy(s) with residual medicaments by the provision of removable filters between the incentive toys and those components comprising a conventional inhaler device. Moreover, the inventors also provided a means of minimising contamination of incentive toys with exhaled air by the inclusion of a filter between the mask and the toy containing module.
Accordingly, one aspect of the present invention provides an incentive inhaler device comprising:
(i) an inhalation device comprising a mask or mouthpiece and a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas; and
(ii) one or more external visible and/or audible inhalation/exhalation-driven incentive toys, wherein each of said toys is separated from one or more components of said inhalation device (i) by one or more valves, filters or baffles to ensure directional flow of inhaled/exhaled air which drives said toys and/or filters to minimise the contaminating effects of drugs and/or condensation.
Preferably, said valves, filters or baffles that ensure directional air flow and/or filtration are positioned within a conduit that provides for the attachment of said inhalation/exhalation-driven incentive toy(s).
In a preferred embodiment, the present invention provides an incentive inhaler device comprising:
(i) an inhalation device comprising a conduit that is operably connected at one end to a mask or mouthpiece and at the other end to a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas, wherein said conduit comprises one or more internal valves, filters or baffles to ensure directional flow of inhaled/exhaled air and/or to ensure proper filtration of exhaled or inhaled air; and
(ii) one or more external visible and/or audible inhalation/exhalation-driven incentive toys, wherein each of said toys is operably connected to said conduit.
Preferably, the modular incentive inhaler device of the present invention further includes a spacer positioned between said inhalation/exhalation mask and said connector. More preferably, the spacer is positioned between said conduit and said connector. In an alternative embodiment, the spacer is positioned between said inhalation/exhalation mask or mouthpiece and said conduit
A second aspect of the invention provides an incentive inhaler device comprising: (i) a mask; (ii) a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas; (iii) two inhalation/exhalation-driven incentive toys; and (iv) a conduit, wherein said conduit comprises three adaptor ends that are connected separately to said mask, connector and incentive toys and wherein said conduit comprises a one-way valve in sealable engagement with the interior wall thereof positioned in the adaptor end that is in engagement with said connector the adaptor to ensure directional flow of inhaled air from the linkable drug delivery device, and wherein each of said incentive toys is separated from said connector by said one-way valve. This aspect of the invention also provides for the option of a filter in one of the other adaptor ends of the conduit which minimises the contamination of incentive toys with particles, microbes and/or condensation present in exhaled air
A third aspect of the invention provides an incentive inhaler device for administering anaesthetic comprising: (i) a mask; (ii) a drug delivery tube that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas; (iii) one or more exhalation-driven incentive toys; and (iv) a conduit, wherein said conduit comprises three adaptor ends that are connected separately to said mask, drug delivery tube and incentive toys and wherein said conduit comprises a first one-way valve in sealing engagement with the interior wall of the adaptor juxtaposed to the incentive toys to prevent the flow of inhaled air from the incentive toys to the mask. This aspect of the invention also provides for the option of a filter in one of the other adaptor ends of the conduit which minimises the contamination of incentive toys with particles, microbes and/or condensation present in exhaled air.
A fourth aspect of the invention provides a connector that is linkable to a drug delivery device or other device for the delivery of an aerosol, powder or gas for use with an incentive inhaler device comprising:
(i) an drug delivery receiving means comprising an aperture at one end to sealably-engage the drug delivery device such that minimum leakage and preferably, no leakage of the chemical compound or drug occurs between the connector and the drug delivery device linked thereto; and
(ii) a threaded portion or snap-lock to releasably- and sealably-engage said connector to the mouthpiece or mask or other component to which said connector is connected or juxtaposed in the assembled incentive inhaler device.
A fifth aspect of the present invention provides a kit comprising two or more of the above connectors, wherein each of said connectors comprises a drug delivery receiving means having an aperture of different dimensions or shape and substantially identical threaded portions or snap-locks such that they are capable of being releasably- and sealably-engaged with the same mouthpiece or mask or other component in the assembled incentive inhaler device.
A sixth aspect of the present invention provides a flexible adaptor end of the connector such that it renders the connector compatible with a variety of drug delivery devices.
A seventh aspect of the present invention provides a method of administering a inhalable medicament to an infant or child subject comprising activating, during the inhalation and/or exhalation phase of breathing of said subject, one or more external visible and/or audible inhalation/exhalation-driven incentive toys that are operably connected to an incentive inhalation device described herein according to any one or more of the embodiments described herein.
The above and other novel features of the present invention will be apparent from the following detailed description, and the accompanying examples and drawings.